[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602231":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":54,"collaborators":57,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":89,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Helsinki University Central Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Women 18-37 years old with a BMI ≥ 25 kg\u002Fm2, metformin 2250mg per day","ACTIVE_COMPARATOR","metformin tablets 2250 mg per day",[13],"Drug: Metformin 2250 mg daily",{"label":15,"type":16,"description":17,"interventionNames":18},"Women 18-37 years old with a BMI ≥ 25 kg\u002Fm2, metformin 1500mg per day","EXPERIMENTAL","metformin tablets 1500 mg per day",[19],"Drug: Metformin 1500 mg daily",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Metformin 1500 mg daily","metformin 500mg tablets, 3 times per day",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Metformin 2250 mg daily","Metformin 750mg, 3 times daily",[9],[32],{"name":33,"affiliation":34,"role":35},"Johanna M Melin, MD","The Reproductive Medicine Unit, Helsinki University Hospital","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+358505382526","johanna.melin@hus.fi",[42],{"facility":34,"status":26,"city":43,"state":26,"zip":26,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Helsinki","Finland","FI",{"type":47,"coordinates":48},"Point",[49,50],24.93545,60.16952,{"lat":50,"lon":49},[53],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},{"type":35,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Johanna Melin","MD, PhD, specialist in obstetrics & gynecology",[58,61,63],{"name":59,"class":60},"Valtion tutkimusraha (funding)","UNKNOWN",{"name":62,"class":60},"Sakari Alhopuro foundation (funding)",{"name":64,"class":60},"The Medical Society of Finland (funding)","100602231","phase-3-optimizing-metformin-use-in-polycystic-ovary-syndrome-100602231",false,"NCT07120815","Optimizing Metformin Use in Polycystic Ovary Syndrome","Optimizing Metformin Use in Polycystic Ovary Syndrome - A Randomized Controlled Trial","MET-PCOS","Inclusion Criteria:\n\n* Diagnosed PCOS (According to the International evidence-based Guideline for PCOS 2023)\n* Age: 18-37 years\n* BMI: ≥ 25 and \\\u003C40 kg\u002Fm2\n* Signed informed consent and willingness to comply with the trial procedures\n* Sufficient skills in the Finnish or Swedish language\n\nExclusion Criteria:\n\n* Not meeting the criteria according to the International evidence-based Guideline for PCOS 2023)\n* Use of hormonal contraceptive during the last 3 months\n* Pregnancy\n* Breastfeeding\n* Untreated diabetes\n* Hypothyroidism\n* Hyperprolactinemia\n* Use of medications for diabetes,\n* Use of medications for high cholesterol\n* Use of medications for obesity\n* Use of medications for cortisone (per oral)\n* Hypersensitivity to metformin\n* Acute metabolic acidosis\n* Renal impairment\n* Hepatic insufficiency\n* Heart- or respiratory failure\n* Serious mental illness\n* Alcoholism\n* Investigator site staff directly involved in the conduct of the study and their family members","FEMALE","18 Years","37 Years",{"count":77,"type":78},184,"ESTIMATED","INTERVENTIONAL",[81],"PHASE3","The goal of this clinical trial is to learn if a metformin dose of 1500 mg or 2250 mg per day is better to treat polycystic ovary syndrome (PCOS) in adults. It will also learn about the adverse effects of metformin. The trial aims to evaluate which metformin dose is better for:\n\n1. improving biochemical and clinical outcomes\n2. gastrointestinal side-effects\n3. mental health and quality of life\n\nParticipants will:\n\n* Be randomized to take metformin at a dose of either 1500mg or 2250mg every day for 6 months\n* Visit the clinic three times during the trial for checkups and tests\n* Answer questionnaires on menstrual cyclicity, mental health, quality of life and side-effects",[84],"Polycystic Ovary Syndrome (PCOS)",[86,87,88],"polycystic ovary syndrome","metformin","randomized controlled trial","NOT_YET_RECRUITING","2025-08-06",{"date":92,"type":93},"2025-08-13","ACTUAL",{"date":95,"type":78},"2025-09-01",{"date":97,"type":78},"2028-12-31",{"name":5,"class":6},1]